At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 2 enrolled
Drug / intervention
BI 201335drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Single Dose Phase I Trial of 120 mg and 240 mg BI 201335 Soft Gel Capsules to Study Pharmacokinetic Properties and Safety in Patients With Compensated Liver Cirrhosis in Historical Comparison With 1220.2
In Brief
A Phase 1 clinical trial evaluating BI 201335 for Hepatitis C and Liver Cirrhosis. Completed, enrolled 2 participants across 1 site.
Detailed Summary
This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (\< 7 points).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Liver Cirrhosis
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
Primary CompletionOct 2008
First PostedJul 2013
TodayJul 2026
First PostedJul 29, 2013
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.9 years ago
Interventions
BI 201335drug
single oral doses